JPRN-UMIN000053762尚未招募Unknown
Prospective Clinical Trial of Moderately Hypo-fractionated Intensity Modulated Radiation Therapy with Concurrent Administration of Daikenchuto for Prostate Cancer - DKTR PRO Trial
Suita Tokushukai Hospital0 个研究点目标入组 125 人开始时间: 2024年4月23日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable(—)
- 性别
- Male
入选标准
- 未提供
排除标准
- •1)Patients with a history of active multiple cancers 2) Patients who are suitable for radical intensity-modulated radiotherapy for prostate cancer, but who are judged to require combination therapy with pelvic irradiation due to pelvic lymph node metastases 3)Patients who have undergone pelvic surgery or radiation therapy before obtaining consent 4)Patients who have been taking regular Chinese herbal medicines including Daikenchuto since before consent was obtained 5) Patients who are already known to be allergic to Daikenchuto and the herbal medicines contained in this drug 6) Patients who are unable to collect urine during radiotherapy due to co-morbidities such as hemodialysis 7) Patients with a history of transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia as a comorbidity 8) Patients who are self-catheterized or have a urinary catheter continuously in place due to urinary retention or severe urinary difficulty as a comorbidity 9) Patients with a history of inflammatory bowel disease such as ulcerative colitis or Crohn's disease as a comorbidity 10)Patients with persistent lower gastrointestinal bleeding symptoms due to hemorrhoids etc. as a comorbidity 11)Patients with interstitial pneumonia as a comorbidity 12)Patients with collagen disease as a comorbidity 13) Patients with serious liver disease (AST (GOT) or ALT (GPT) 100 U or more) 14) Patients with severe renal disease (creatinine 2.0 mg/dl or more) 15)Other patients deemed unsuitable as research subjects by the research director
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